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  5. Label Information: Ex-lax Regular Strength Stimulant Laxative

FDA Label for Ex-lax Regular Strength Stimulant Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS (0067-0003)
    14. INACTIVE INGREDIENTS (0067-8141)
    15. QUESTIONS ?
    16. PRINCIPAL DISPLAY PANEL

Ex-lax Regular Strength Stimulant Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablet)



Sennosides 15 mg


Purpose



Stimulant laxative


Uses



  • •relieves occasional constipation (irregularity)
  • •generally produces bowel movement in 6 to 12 hours

Do Not Use



laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor


Ask A Doctor Before Use If You Have



noticed a sudden change in bowel habits that persists over a period of 2 weeks


Ask A Doctor Or Pharmacist Before Use If You Are



taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.


When Using This Product



do not use for a period longer than 1 week


Stop Use And Ask A Doctor If



rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • •swallow tablet(s) with a glass of water
  • •swallow tablet(s) whole, do not crush, break or chew

    • adults and children 12 years of age and older

    2 tablets once or twice daily

    children 6 to under 12 years of age

    1 tablet once or twice daily

    children under 6 years of age

    ask a doctor


Other Information



  • •each tablet contains: calcium 45 mg, magnesium 5mg
  • •store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients (0067-0003)



acacia, alginic acid, carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, iron oxides, magnesium stearate, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide


Inactive Ingredients (0067-8141)



acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide


Questions ?



call 1-855-221-5432


Principal Display Panel



NDC 0067-0003-30

Regular Strength

ex•lax®

SENNOSIDES, USP, 15 mg

STIMULANT LAXATIVE

RELIEF GUARANTEED EVERY TIME

GENTLE OVERNIGHT RELIEF YOU CAN TRUST

The Ex•Lax® Guarantee: When taken as directed, Ex•Lax® is guaranteed to work gently and effectively overnight or your money back. Return product to Novartis, attention Consumer Affairs, for full refund.

Tamper Evident Feature: Ex•Lax® Pills are sealed in blister packets. Use only if the individual seal is unbroken.

Trademarks are owned by or licensed to GSK group of companies

Distributed by: Novartis Consuemr Health, Inc.

Parsippany, NJ 07054-0622

Ex-Lax RS Pills PDP - 62544c2f 6e30 4cec ae63 233715ef0699 01

Ex-Lax RS Pills PDP - 62544c2f 6e30 4cec ae63 233715ef0699 01

NDC 0067-8141-02

ex•lax®

SENNOSIDES, 15 mg

REGULAR STRENGTH

STIMULANT LAXATIVE

RELIEF GUARANTEED

GENTLE OVERNIGHT RELIEF YOU CAN TRUST

The Ex•Lax® Guarantee: When taken as directed, Ex•Lax® is guaranteed to work gently and effectively overnight or your money back. Return product to GSK, attention Consumer Affairs, for full refund.

Tamper Evident Feature: Ex•Lax® Tablets are sealed in blister packets. Use only if the individual seal is unbroken.

Trademarks are owned by or licensed to the GSK group of companies.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

©2017 GSK or its licensor. All rights reserved

13143


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